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Last Updated: March 2, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020883

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NDA 020883 describes ARGATROBAN, which is a drug marketed by Amneal Pharms Co, Fresenius Kabi Usa, Hikma Pharm Co Ltd, Hospira Inc, Mylan Institutional, Novartis, Par Sterile Products, Teva Pharms Usa, Sandoz, Eagle Pharms, Gland Pharma Ltd, and Aurobindo Pharma Ltd, and is included in thirteen NDAs. It is available from eight suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the ARGATROBAN profile page.

The generic ingredient in ARGATROBAN is argatroban. There are eleven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the argatroban profile page.
Summary for 020883
Tradename:ARGATROBAN
Applicant:Novartis
Ingredient:argatroban
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020883
Mechanism of ActionThrombin Inhibitors
Suppliers and Packaging for NDA: 020883
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARGATROBAN argatroban INJECTABLE;INJECTION 020883 NDA Novartis Pharmaceuticals Corporation 0078-0930 0078-0930-61 1 VIAL in 1 CARTON (0078-0930-61) > 2.5 mL in 1 VIAL
Paragraph IV (Patent) Challenges for 020883
Tradename Dosage Ingredient NDA Submissiondate
ARGATROBAN INJECTABLE;INJECTION argatroban 020883 2007-09-24

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength250MG/2.5ML (100MG/ML)
Approval Date:Jun 30, 2000TE:APRLD:Yes

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